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Assessing Equivalence in Rheumatoid Arthritis in Clinical Trials

Statistical Consultancy Team

In Rheumatoid Arthritis (RA) clinical trials, treatment response is often assessed via the American College of Rhematology (ACR) composite responder score ACR20. This is a binary criterion that incorporates several indices of treatment activity in terms of symptoms reduction and is equal to 1 if at least 20% of improvement between a baseline and post-baseline measurement is observed in tender and swollen joint counts, in at least three out of five other indicators (C-Reactive Protein, patient global assessment of disease activity, physician global assessment of disease activity, patient pain scale, Health Assessment Questionnaire Disability Index), and 0 otherwise.

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Topics: Statistical Programming, Biostatistics Consulting, Rheumatoid Arthritis (RA), PROC NLMIXED

Comparing treatment response curves: a practical example in rheumatoid arthritis

Statistical Consultancy Team

Nowadays, more and more studies are being designed to collect information on treatment response at several time points during the treatment period of the study. Although the primary endpoint is often the comparison at the end of the study of the absolute response or of the change to baseline between study treatments, analyses involving intermediate time points in the assessment of treatment effects, e.g., repeated measures modeling, are now widely used.

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Topics: Programming R, SAS Programming, Therapeutic Areas, Biostatistics Consulting, Phase 3 Studies, Rheumatoid Arthritis (RA), PROC NLMIXED, PROC IML

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